MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P 612

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated the cobas p612 preanalytical system suddenly shut down.When they investigated, the power source was warm to the touch and the power cord was melted.The customer unplugged the system.No one was harmed due to the event.The field service representative found a failure of the fuse and/or ac power cable.He replaced the interface assembly and fuses and returned power to the system.The system operated per specification.No past or new complaints of this nature on a like instrument have been received in the past year.

Manufacturer Narrative

The initial mdr stated, "no past or new complaints of this nature on a like instrument have been received in the past year." the initial mdr should have stated that no past or new complaints of this nature on a like instrument have been received in the past year at this customer's site.One other complaint of a similar nature was found.

Manufacturer Narrative

The field engineer checked the ups, ac power at the customer's site, and equipment ground, which were normal and within specification.

Manufacturer Narrative

The investigation found the device was incorrectly configured during installation.The device was configured for 230 volt, 50 hz rather than 120 volt, 60 hz.There was no failure of the device.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6383840
• MDR Text Key: 69328805
• Report Number: 1823260-2017-00483
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P 612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/16/2017
• Supplement Dates FDA Received: 03/21/2017; 05/01/2017; 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1